Kornimate/medical-research-clean huggingface dataset:
a study of ray1225 in participants with impaired liver function

Conditions: Hepatic Impairment

Summary: the purpose of this study is to assess how fast ray1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.


Eligibility criteria:
inclusion criteria: 1. participant must be ≥ 18 to ≤ 75 years; 2. bmi ≥ 20 kg/m2 up to ≤ 32 kg/m2; 3. participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product; 4. signature of a dated informed consent form (icf) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment; 5. egfr ≥ 60 ml/min/1.73 m2; participants with normal hepatic function only: 6. healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function; participants with hepatic impairment only: 7. males or females with chronic mild and moderate liver impairment, assessed by child-pugh scoring. exclusion criteria: 1. participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product; 2. qtcf\> 450ms; 3. participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks; 4. participates who donated blood or bleeding profusely (\> 400 ml) in the 3 months; 5. pregnant or lactating women, or women of childbearing age with a positive pregnancy test; 6. smoking averaged more than 10 cigarettes per day in the 3 months prior to screening; 7. have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; participants with normal hepatic function only: 8. any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening. participants with hepatic impairment only: 9. any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders. 10. participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.
the effect of therapeutic touch on colic symptoms in infantile colic infants: a randomized controlled study

Conditions: Infantile Colic; Therapeutic Touch

Summary: aim: the purpose of this study is to determine the effect of therapeutic touch applied to infants with infantile colic on infant colic scale score, crying and sleep time. method: the study will be conducted as a single-blind, randomized controlled trial. the population of the study will be infants who come to the pediatrics outpatient clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. the infants will be divided into two groups as intervention and control groups according to stratified block randomization in the computer environment. after the randomization, therapeutic touch will be applied to the intervention group. no method will be applied to the control group.

the research will be carried out with two groups as intervention and control groups. sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. according to the analysis results, it has been calculated as 27 for each group and 54 in total. considering the possible case losses, 20% of the sample was increased. the sample consisted of 64 babies, 32 intervention and 32 control. mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. written consent will be obtained. the infants will be divided into two groups according to stratified block randomization in the computer environment. the infants will be stratified by gender and age. after the randomization, therapeutic touch will be applied to the intervention group. no method will be applied to the control group by the researcher. in obtaining research data, 4 tools will be used: "mother-infant information form", "infantile colic scale", crying time registration form and sleep time registration form.

Eligibility criteria:
inclusion criteria: * family volunteering to participate in the research * the infant was born at term * the infant is between 4 weeks and 12 weeks * the birth weight is between 2500-4500 g * the infant has been diagnosed with infantile colic according to wessel criteria * mothers' ability to read, write and speak turkish * new diagnosis of infantile colic exclusion criteria: * the infant has any chronic illness and congenital anomaly * mothers have diagnosed mental and mental problems * mother smoking * the diagnosis of lactose intolerance to infants by the physician

Keywords: therapeutic touch infantile colic infant nursing symptom
a study on the infusion regimen of piperacillin-tazobactam in patients aged 65 and older with pneumonia

Conditions: Pneumonia

Summary: pneumonia is characterized by high incidence and mortality rates in elderly patients (≥65 years old). piperacillin-tazobactam, as a broad-spectrum antibiotic, has its therapeutic efficacy and safety potentially influenced by the infusion regimen. however, research on infusion regimens specifically targeting the elderly population is currently limited. in our preliminary dose simulation, under the pharmacokinetic/pharmacodynamic (pk/pd) target of achieving a free drug concentration time percentage above 100% of the minimum inhibitory concentration (ft%\>100% mic), the regimen of administering the drug every 6 hours (q6h) achieved a concentration compliance rate of 90% within 4 hours. this study aims to explore the differences between two infusion modes (q6h for 4 hours vs. q8h for 3 hours) and to provide preliminary evidence for clinical practice.


Eligibility criteria:
inclusion criteria: age must be greater than 65 years clinical diagnosis of pneumonia receiving intravenous piperacillin-tazobactam treatment exclusion criteria: history of allergy to β-lactam antibiotics continuous renal replacement therapy, severe organ dysfunction malignant tumor disease
safety of expanded haploidentical natural killer cells for leukemia

Conditions: Leukemia, Acute Myeloid; Leukemia, Acute Lymphoblastic

Summary: the purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (nk) cells for patients with leukemia.

immunotherapy with natural killer (nk) cells may improve the results of treatment for patients with cancer. however, for better efficiency high doses of nk cells are required. for this purpose, nk cells were expanded in the presence of feeder k562 cells gene-modified for expression 4-1bbl and membrane bound il-21. in the result of expansion, large number of activated nk cells are obtained. protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other protocol of chemotherapy) followed by expanded nk cells intravenous infusion. to sustain proliferation of donor nk cells in vivo patients receive 6 doses of il-2 every second day. 10 patients will be enrolled in phase i to test different doses of nk cells: 20, 50, 70, 100 and \>100 x 10\^6/kg.

Eligibility criteria:
inclusion criteria: patients: * relapsed acute myeloid or lymphoblastic leukemia * primary refractory myeloid or lymphoblastic leukemia * karnofsky or lansky performance scale greater or equal to 70 * written informed consent donor: * haploidentical family donor * \> 18 years old * donor suitable for cell donation and apheresis according to standard criteria * written informed consent exclusion criteria: patients: * uncontrolled infection * severe hepatic dysfunction: sgot or scpt \>=5x upper limit of normal for age * positive serology for human immunodeficiency virus (hiv) donors: * pregnancy or breast feeding * positive serology for hiv, hepatitis b or c.

Keywords: immunotherapy natural killer cells
extension study to evaluate safety and efficacy of jaktinib in adults with alopecia areata

Conditions: Alopecia Areata

Summary: this study (unique protocol id: zgjak020) as an extension of the ongoing "study to evaluate safety and efficacy of jaktinib in adults with alopecia areata (unique protocol id:zgjak020)" study. after completion of zgjak018 study, the study will be directly extend with an "open-label design".


Eligibility criteria:
inclusion criteria: * subjects voluntarily sign the informed consent form. * patients who participated in zgjak018. exclusion criteria: * subjects who are unsuitable to the trial, as identified by the investigator.
study of modafinil to treat fatigue in persons with traumatic brain injury

Conditions: Fatigue

Summary: the purpose of this study is to determine whether modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (eds) in individuals with traumatic brain injury (tbi); and (2) improving cognitive function and quality of life in individuals with tbi.

background: an estimated 5.3 million americans are living with a tbi-related disability today. these persons may face many issues, however, two chronic problems seem common to a strikingly large number of those who survive tbi: fatigue and eds. need for research: modafinil has been shown to be useful for fatigue and sleepiness in patients with depression, multiple sclerosis, parkinson's disease and individuals with eds secondary to a variety of sleep disturbances. however, there has not been any controlled evaluation of modafinil use for the treatment of individuals with tbi to date. current and future research activity: approximately 60 participants with post-tbi fatigue will be randomly assigned to two 10-week periods of taking either modafinil or placebo. participants taking modafinil during the first 10 weeks will be switched to placebo for the second 10 weeks. similarly, participants taking placebo during the first 10 weeks will be switched to modafinil for the second 10 weeks. outcomes relating to fatigue and eds will be collected weekly throughout the study. other outcomes (including general health, depression, and cognitive function) will be collected at the start of each period, 4 weeks into each period, and again at the end of each period. it is hypothesized that participants taking modafinil will report significantly less fatigue and eds, report significantly better general health and depression scores, and perform significantly better on tests of cognitive performance in comparison to participants taking placebo.

Eligibility criteria:
inclusion criteria: * individuals who sustained a tbi * were discharged from craig hospital following initial rehabilitation * are at least one year post-injury * have disabling symptoms of fatigue and/or eds which compromise their ability to function optimally * (if female) are surgically sterile, two years post-menopausal, or if of childbearing potential, are using a medially acceptable method of birth control and agree to continue use of this method for the duration of the study exclusion criteria: * individuals who have neurologic and/or neuropsychiatric difficulties and/or deficits which will obscure the evaluation of this medication's effectiveness - * have a diagnosis of other likely causes of eds * have concurrent medication use and/or clinically significant systemic disease that may cause fatigue and/or diminished arousal * have epilepsy * currently use of any anti-epileptic medications or warfarin * have cardiovascular disease or risks * have severe renal or hepatic impairment * have significant psychiatric or behavioral disturbance which would obscure the evaluation of medication effectiveness * are a pregnant or lactating female

Keywords: traumatic brain injury fatigue modafinil somnolence
plasma biomarkers c-rac, icorg 12-27, v1

Conditions: Colorectal Cancer

Summary: this is an exploratory, translational, non-interventional and multi-centre clinical study.

cohort a will consist of 100 crac patients with stage ii/iii resectable disease due for adjuvant chemotherapy. cohort b will consist of 30 patients with stage ii resectable disease for observation only. both cohorts will have a follow up period of up to 2 years, post chemotherapy for cohort a and post resection for cohort b.

Eligibility criteria:
inclusion criteria: * patient must be able to give written informed consent * histologically or cytologically confirmed crac * cohort a: colorectal cancer patients with stage ii/iii resectable disease due for adjuvant chemotherapy or cohort b: colorectal cancer patients with stage ii resectable disease for observation only * age ≥ 18 years * treatment with curative intent * eastern cooperative oncology group (ecog) performance status 0 - 2 exclusion criteria: * presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient when participating in this trial * evidence of a metastatic disease

Keywords: curative resection adjuvant chemotherapy
efficacy of transitional case management following psychiatric hospital discharge

Conditions: Mental Disorders

Summary: efficacy of transitional case management following psychiatric hospital discharge: a randomized trial background the movement of deinstitutionalisation in western societies has modified the role of psychiatric hospital, which has lost its asylum function to become a place for acute care. psychiatric stays are now shorter and close interactions with the outpatient care network is therefore more critical than before. the first weeks following discharge from psychiatric hospital represent a period of high risk for relapse, readmission or even suicide. case management has a proven efficacy in facilitating patients' deinstitutionalisation after very long hospitalisations and in stabilizing high users of psychiatric care. in contrast, studies exploring the impact of time limited case management following discharge from short stays (transitional case management) in earlier phases of psychiatric disorders in connection with primary care are lacking. working hypotheses the investigators hypothesize that transitional case management following hospital discharge decreases risk of readmission, improves adherence to outpatient care, facilitates recovery and improves patients' satisfaction with treatment as compared to routine care. specific aims in this study, the investigators will compare the impact of both intervention on number of contact and level of adherence to outpatient care. the investigators will also compare both groups on number of readmission, risk of early aggravation of the disorders, level of functioning and satisfaction with care. methods this is a randomized single-blind study comparing transitional case management after discharge with routine post-hospitalization care for subjects living independently without institutional psychiatric follow-up. demographic and clinical data will be gathered during hospitalization, and 1, 3, 6 and 12 months after discharge. quantitative assessment of outcomes using validated instruments will be: contact and level of adherence to outpatient care (primary outcomes), as well as number of hospitalization days, number of readmissions, severity of illness and satisfaction with care (secondary outcomes). expected value of the proposed project this study should improve psychiatric patients follow-up in collaboration with the different levels of care in the global context of deinstitutionalization.


Eligibility criteria:
inclusion criteria: * patients are 18-65 years of age * no immediate institutional follow up after discharge * independent living condition exclusion criteria: * organic brain disease * clinically significant concurrent illnesses * poor understanding of french

Keywords: case management psychiatric hospitalization discharge
correction of enophthalmos and orbital volume using pre-bent mesh versus 3d printed onlay in orbital fracture cases

Conditions: Orbital Fractures; Enophthalmos; Periorbital Fracture

Summary: this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3d printed only versus pre-bent titanium mesh in blow-out fracture cases

many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3d printed onlay versus pre-bent titanium mesh

Eligibility criteria:
inclusion criteria: * adult patients (≤17 years old). * blow-out orbital fracture. * unilateral orbital trauma. * enophthalmos (≤ 2 mm). * patients with contralateral healthy, non-surgically operated orbit. exclusion criteria: * young patients (\> 17 years old). * patients with systemic diseases. * bilateral orbital trauma. * enophthalmos (\>2 mm). * patients whom cannot tolerate follow up intervals.

Keywords: 3d printed onlay peek orbital mesh computer-guided surgery
avon foundation program to improve quality of life in breast cancer survivors

Conditions: Breast Cancer

Summary: women with breast cancer often suffer significant distress and disability from their disease. a practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with breast cancer decrease their suffering and improve their quality of life.

the objective of this study in women recently treated for breast cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. quality of life will be assessed at 12 months.

Eligibility criteria:
inclusion criteria: all women with stage i-iii breast cancer who have received treatment within the preceding year will be eligible for inclusion in the study. exclusion criteria: 1. patients who refuse to participate will be excluded 2. patients with metastatic (stage iv) cancer are excluded.

Keywords: meditation stress-reduction cognitive-affective behavior learning
evaluation of image-based modelling on clinical decisions in coarctation of the aorta

Conditions: Congenital Heart Disease; Aortic Coarctation; Cardiovascular Disease

Summary: to answer the research question: "would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.

in collaboration with our three clinical partners, we will first generate two separate imaging datasets for a maximum of three patients recruited to participate in cardioproof. the first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset"). the second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset"). we will generate both limited and image-based modelling datasets from fully de-identified patients already enrolled in cardioproof (nct02591940) who have consented to publication of data in anonymized form. using a computerized random-sample function, we will randomly allocate interventional cardiologists into two separate groups and present them with one set of imaging data. the first group will receive a "limited" dataset including only information that is available from traditional diagnostics (as recommended by the clinical practice guidelines) for a pre-specified number of patients (maximum of 3). the second group will receive the full, detailed dataset inclusive of information that is available from traditional diagnostics (as recommended by the guidelines) and simulation modelling for the same set of patients. we will then ask the interventional cardiologists in the two groups to make (hypothetical) clinical decisions using the dataset of imaging parameters presented to them. the clinical decisions will be hypothetical because patients will have been treated according to clinical practice guidelines and this experiment will retrospectively involve interventional cardiologists who are not directly involved in the care of the patients participating in cardioproof. the analysis will focus on each hypothetical scenario and compare the proportions of cardiologists making different types of intervention decisions in the two randomly allocated groups.

Eligibility criteria:
inclusion criteria: * practicing interventional cardiologists * has treated patients with coarctation of the aorta during the past 6 months exclusion criteria: * participation in cardioproof trial

Keywords: cardiovascular modeling aortic coarctation virtual stenting
effectiveness of using a chatbot to promote adherence to home physiotherapy

Conditions: Knee Osteoarthritis

Summary: a chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. the tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. a randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. the participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).


Eligibility criteria:
inclusion criteria: * individuals on the waiting list for total knee replacement surgery * undergoing primary total knee replacement surgery * who have a personal smartphone * who have an instant messaging application installed * familiar with the use of such application (more than 3 accesses per week), exclusion criteria: * evident cognitive state that prevents to understand care provider instructions * vestibular or central nervous system affection (e.g. stroke) * cannot read or write * do not understand spanish language * not able to consent to participate